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Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected. The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified. The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes. It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.
According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion. The risk and benefit were informed and the informed consent of the subjects was signed. The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer. The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed. Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservation of pulmonary vagus nerve | Experimental | Preservation of pulmonary branches of vagus nerve in minimally invasive surgery for lung cancer |
|
| No pulmonary vagus nerve preservation | Experimental | In minimally invasive surgery for lung cancer, the pulmonary branches of vagus nerve were severed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In minimally invasive surgery，Vagus nerve preservation | Other | In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve |
| Measure | Description | Time Frame |
|---|---|---|
| cough after pulmonary resection | (1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| pulmonary infection | Postoperative pneumonia should be considered if there are three or more of the following indicators:
If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Atelectasis | (1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| hydrothorax | Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days. | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Postoperative respiratory failure or ARDS or requiring tracheal intubation | Tracheal intubation; Ventilator; ICU |
| Measure | Description | Time Frame |
|---|---|---|
| Operation time; | Operation time; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Intraoperative bleeding volume; | Intraoperative bleeding volume; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenli Wang, Master's degree | Contact | 13761295864 | 86021661110 | Anderson840913@163.com |
| Yongxin zhou, Doctor | Contact | 13681666828 | zhou6302@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yongxin zhou, Doctor | Tongji Hospital affiliated to Tongji University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yongxin Zhou | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26273360 | Result | Chen W, Zheng R, Zeng H, Zhang S. Epidemiology of lung cancer in China. Thorac Cancer. 2015 Mar;6(2):209-15. doi: 10.1111/1759-7714.12169. Epub 2015 Mar 2. | |
| 15620960 | Result | Sawabata N, Maeda H, Takeda S, Inoue M, Koma M, Tokunaga T, Matsuda H. Persistent cough following pulmonary resection: observational and empiric study of possible causes. Ann Thorac Surg. 2005 Jan;79(1):289-93. doi: 10.1016/j.athoracsur.2004.06.045. |
| Label | URL |
|---|---|
| pubmed | View source |
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120 patients were divided into two groups. One group retained the pulmonary vagus nerve and the other group severed the vagus nerve.
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| In minimally invasive surgery，Vagus nerve is not preserved | Other | In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve. |
|
| From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Postoperative drainage volume; | Postoperative drainage volume; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Postoperative mortality | Postoperative mortality | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Postoperative cardiovascular complications | Postoperative cardiovascular complications | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Re-admission ICU rate; | Re-admission ICU rate; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Time of stay in ICU; | Time of stay in ICU; | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Hospitalization days | Hospitalization days | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| Hospitalization expenses | Hospitalization expenses | From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks. |
| 14769722 | Result | Sarna L, Evangelista L, Tashkin D, Padilla G, Holmes C, Brecht ML, Grannis F. Impact of respiratory symptoms and pulmonary function on quality of life of long-term survivors of non-small cell lung cancer. Chest. 2004 Feb;125(2):439-45. doi: 10.1378/chest.125.2.439. |
| 27659172 | Result | Weijs TJ, Goense L, van Rossum PSN, Meijer GJ, van Lier AL, Wessels FJ, Braat MN, Lips IM, Ruurda JP, Cuesta MA, van Hillegersberg R, Bleys RL. The peri-esophageal connective tissue layers and related compartments: visualization by histology and magnetic resonance imaging. J Anat. 2017 Feb;230(2):262-271. doi: 10.1111/joa.12552. Epub 2016 Sep 23. |
| pubmed | View source |
| pubmed | View source |
| pubmed | View source |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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